EMEA Releases Guidelines On Development Of Medicines For Alzheimer’s Disease And Parkinson’s Disease

The European Medicines Agency (EMEA) has released two guidelines for
companies developing medicines for the treatment of Alzheimer’s disease
and other dementias, and for Parkinson’s disease, in the light of recent
scientific progress in the understanding of these diseases and
conditions.

Advances in clinical science, physiopathology and molecular biology have
stimulated new interest in the development of more effective symptomatic
or disease-modifying treatments, i.e. early treatments that may prevent
the emergence or slow down the progression of disease. The guidelines
were developed in response to the need of companies developing these new
types of medicines for guidance on appropriate clinical-trial designs.

As life expectancy increases, neurodegenerative diseases and dementia
will affect more and more people over the coming decades, and these
guidelines are expected to help improve the availability of medicines to
treat such diseases and conditions. The guidelines will come into effect
on 1 February 2009.

Scientific guidelines, which help companies to submit valid
marketing-authorisation applications for their medicines, are prepared
by the EMEA’s expert bodies, in this case the Committee for Medicinal
Products for Human Use (CHMP) and its relevant working parties, in
consultation with the Agency’s stakeholders. They reflect an approach to
specific scientific issues that is harmonised across the European Union
(EU), and are based on the most up-to-date scientific knowledge.
However, the recommendations they contain are not binding, and sponsors
may deviate from them, provided they can substantiate their approach.

The therapeutic area of neurodegenerative diseases is part of the
mandatory scope of the centralised procedure for the authorisation of
medicines. This means that, in the EU, all applications for marketing
authorisation for new medicines in this area have to be submitted to the
EMEA. The other therapeutic areas in the mandatory scope are: HIV/Aids,
cancer, diabetes, autoimmune diseases and other immune dysfunctions, and
viral diseases.

Notes

1. The ‘Guideline on medicinal products for the treatment of Alzheimer’s
disease and other dementias’ (CPMP/EWP/553/95 Rev.1) can be found
here (PDF). The ‘Guideline on
clinical investigation of medicinal products in the treatment of
Parkinson’s disease’ (CHMP/563/95 Rev.1) can be found
here (PDF).

2. These guidelines are substantially revised versions of earlier EMEA
guidelines, and have been updated to reflect new scientific
understanding of Alzheimer’s disease, dementia and Parkinson’s disease.

3. The guidelines were released for public consultation in July 2007.
Comments received during the consultation phase will be published on the
EMEA website shortly.

4. This press release, together with other information on the work of
the EMEA, can be found on the EMEA website: emea.europa.eu

EMEA

Swine Flu And Asthma: NIH Prepares To launch 2009 H1N1 Influenza Vaccine Trial In People With Asthma

The National Institutes of Health is preparing to launch the first government-sponsored clinical trial to determine what dose of the 2009 H1N1 influenza vaccine is needed to induce a protective immune response in people with asthma, especially those with severe disease. The study is cosponsored by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Heart, Lung, and Blood Institute (NHLBI), both part of NIH.

“People with severe asthma often take high doses of glucocorticoids that can suppress their immune system, placing them at greater risk for infection and possibly serious disease caused by 2009 H1N1 influenza virus,” says NIAID Director Anthony S. Fauci, M.D. “We need to determine the optimal dose of 2009 H1N1 influenza vaccine that can be safely administered to this at-risk population and whether one or two doses are needed to produce an immune response that is predictive of protection.”

The study plan has been submitted to the Food and Drug Administration for review. With FDA allowing it to proceed, the clinical trial will be conducted at seven sites across the United States that participate in NHLBI’s Severe Asthma Research Program.

This program already has a well-characterized group of participants with mild, moderate or severe asthma who may be eligible for this new study. These groups are largely distinguished by the amount and frequency of glucocorticoids needed to control asthma symptoms. People with mild disease may not need glucocorticoids, or may require low doses of inhaled glucocorticoids; those with moderate asthma need low to moderate doses of inhaled glucocorticoids; and those with severe asthma need high doses of inhaled glucocorticoids and frequently use oral glucocorticoids as well.

Individuals who already have been infected with 2009 H1N1 influenza or have received a 2009 H1N1 influenza vaccination will not be eligible for the study.

“The results of this study will have immediate implications for individuals with severe asthma as well as those who have milder asthma,” says NHLBI Director Elizabeth G. Nabel, M.D.

Early results from other clinical trials of 2009 H1N1 influenza vaccines in healthy adults have shown that a single 15-microgram dose of 2009 H1N1 influenza vaccine without adjuvant is well tolerated and induces a strong immune response in most participants. The same vaccine also generates an immune response that is expected to be protective in healthy children ages 10 to 17 years. Ongoing trials are comparing the immune response to one and two doses of 15- or 30-micrograms of vaccine given three weeks apart in various populations.

The Centers for Disease Control and Prevention has recommended that certain at-risk populations receive the new H1N1 vaccine as a priority before the general population. These target populations include pregnant women, health care providers and individuals with underlying chronic medical conditions, including asthma.

People who have severe asthma may be particularly at risk for infection with the 2009 H1N1 influenza virus. A report published in 2004 suggested that some people who took high doses of glucocorticoids to treat their asthma may receive less protection from influenza vaccines against some strains of influenza. Early in the 2009 H1N1 flu outbreak a CDC review of hospital records found that people with asthma have a four-fold increased risk of being hospitalized with infection compared to the general population.

The study will enroll approximately 350 people with mild, moderate and severe asthma. Participants will be organized into two groups: those with mild or moderate asthma and those with severe asthma. Half of the participants in each group will receive a 15-microgram dose of vaccine, and the other half a 30-microgram dose. Three weeks later, each participant will receive a second dose of the same amount. The strength of the immune response induced by the vaccine will be determined in blood samples by measuring the level of antibodies against 2009 H1N1 flu virus.

Safety data will be collected and examined throughout the course of the study by trial investigators and by an independent safety monitoring committee. Participants will be monitored for any side effects they may experience because of the vaccine, as well as asthma attacks that occur during the study period.

The vaccine to be used in the trial, manufactured by Novartis, contains inactivated 2009 H1N1 influenza virus and therefore cannot cause anyone to become infected with the virus.

The trial will be conducted at the following locations:
Cleveland Clinic, Ohio

Emory University, Atlanta

University of Pittsburgh Asthma Institute

University of Virginia, Charlottesville

University of Wisconsin, Madison

Wake Forest University, Winston-Salem, N.C.

Washington University School of Medicine, St. Louis

Detailed information about this study can be found on the ClinicalTrials Web site at clinicaltrials/ct2/results?term=H1N1+AND+asthma.

Source:
NIAID Office of Communications

NIH/National Institute of Allergy and Infectious Diseases

UnitedHealth Group Supports Tornado Victims In Southern States

UnitedHealth Group (NYSE: UNH) and its family of companies, including UnitedHealthcare, Ovations, AmeriChoice, OptumHealth and Prescription Solutions, are taking immediate action to assist people in the 17 county disaster area who may have been affected by the recent Mississippi tornadoes. This includes relief to health plan participants who may need to refill prescription medications that may have been misplaced as a result of the tornado; opening a free counseling help line; and a $20,000 donation toward the American Red Cross Disaster Relief Fund, which will help support people affected by the tornadoes in the Southeast United States.

- Early Prescription Refills: Individuals who have been displaced or do not have access to their medications, who call and identify that they have been affected by the tornado, will be able to have prescription medications filled if they have refills remaining on file at a participating retail or mail-order pharmacy.

This includes plan participants enrolled in all fully insured commercial products, Medicare Advantage, Medicare Supplement or Medicare Part D offerings, AARP MedicareRx plans and UnitedHealthcare Mississippi CHIP programs. For mail-order delivery service to affected areas or any other questions related to their prescriptions, people are encouraged to call the pharmacy number on the back of their ID card, or speak directly to a pharmacist about their situation.

This policy is effective immediately and will remain active until at least May 10, 2010.

- Help Line for Community Residents – OptumHealth, UnitedHealth Group’s health and wellness business, is providing a free help line for people coping with the emotional consequences of the tornadoes. Staffed by experienced master’s-level behavioral health specialists, the help line offers assistance to callers seeking help in dealing with stress, anxiety and the grieving process. Callers may also receive referrals to community resources to help them with specific concerns, such as financial and legal issues.

The toll-free help line number, 866-342-6892, is available 24 hours a day, seven days a week for as long as necessary. This service is free of charge to all Mississippians even if they are not UnitedHealthcare customers. Resources and information are also available online at liveandworkwell and in Spanish at mentesana-cuerposano.

- Support for the American Red Cross – A $20,000 donation will go to the American Red Cross Disaster Relief Fund from UnitedHealthcare, which provides services to the State of Mississippi under the Children’s Health Insurance Program, as well as to employer groups throughout the state.

“Our thoughts and prayers are with the people of Yazoo City and surrounding communities who suffered such tragic losses of life and property in this disaster,” said Norine Yukon, executive director of UnitedHealthcare Mississippi CHIP plan. “We recognize the Red Cross as an organization that can immediately have a positive impact for the people affected, and we want to support them as they assist Mississippians.”

UnitedHealth Group participates in the Annual Disaster Giving Program of the American Red Cross. The donation will allow the Red Cross to provide support for shelters, meals, and clean-up and comfort kits, as well as mental health support for families and the Yazoo City community.

“UnitedHealthcare is a committed partner of the Red Cross in disaster preparedness and relief,” said Michael Brown, vice president of Corporate and Foundation Partnerships at the American Red Cross. “Through their support of the Annual Disaster Giving Program, we are able to respond immediately to provide lifesaving services to families and communities during disasters like the recent tornado in Mississippi.”

People interested in providing additional assistance can contact the Red Cross Disaster Relief Fund to help provide food, shelter and counseling for people affected by disasters like the recent tornado by logging onto RedCross or by calling 1-800 RED CROSS (1-800-733-2767) or 1-800-257-7575 (Spanish) to make a donation. Contributions to the Disaster Relief Fund may also be sent to a local American Red Cross chapter or to the American Red Cross, P.O. Box 37243, Washington, D.C., 20013.

Source
American Red Cross
UnitedHealth Group

Your pillow is riddled with nasty fungi

Many years ago many of us switched from feathered to synthetic pillows thinking they were better for us – but it seems synthetic pillows harbour many more fungi than feathered ones, say researchers at the University of Manchester.

You can read about this study in the journal Allergy.

The scientists found over 16 different types of fungi in pillows. They identified an abundance of a type of fungus that worsens asthma symptoms.

Ten pillows were looked at, half of them feathered, the other half synthetic. Pillows ranged from 18 months use to two decades. They found that the fungi live off our skin scales as well as the excrements of dust mites.

Every single pillow they studied had a ‘substantial’ amount of fungi, said the researchers. Some pillows had 4 types of fungi while others had as many as 16.

They found synthetic pillows had much more of the type of fungus which makes asthma symptoms worse – Aspergillus fumigatus (feathered pillows had much less).

These findings have implications for people with respiratory diseases, say the researchers. We spend one third of our lives lying on pillows.

It seems we are better off with feathered pillows, after all. We must definitely disinfect our pillows more often.

:

Pandemic Flu, Access To Health Care, Emergency Preparedness, Disparities Among Top Public Health Concerns, USA

Thousands of public health experts, researchers and administrators will gather in Boston, Nov. 4-8, to discuss the latest in public health research and practice and debate policy concerns affecting the profession and the health of the nation at the American Public Health Association’s 134th Annual Meeting and Exposition.

Themed Public Health and Human Rights, the meeting will explore the right to health and the impact of social inequalities, disparities in access to and delivery of health care and other social determinants in affecting health outcomes. The conference will also include hundreds of sessions on other pressing issues in public health such as pandemic influenza, emergency contraception, HIV/AIDS, disaster preparedness, chronic disease prevention and control and health disparities.

The meeting kicks off with keynote addresses by Paul E. Farmer, M.D, Ph.D., founding director of Partners in Health, and Helene D. Gayle, M.D., M.P.H., president and chief executive officer of CARE USA, at the Opening General Session at noon on Sunday, Nov. 5, in the Boston Convention and Exhibition Center.

The weeklong conference features more than 900 scientific sessions where attendees can access the most up-to-date public health research reflecting the broad impact this field has in our lives. The full Annual Meeting program and abstracts are searchable at apha/meetings. During the meeting, the Association will also consider adopting a wide range of proposed policies, including encouraging wide-scale pandemic flu planning, ensuring that patients can have contraceptive prescriptions filled at pharmacies, supporting a global framework convention on alcohol control and urging action to reverse the nation’s obesity epidemic.

Press information is available at apha/news/annual. Final programs with session locations, along with daily news media updates will be available on site at the APHA Press Office, Room 102A of the Boston Convention and Exhibition Center. Journalists must display a registration badge to gain entry to sessions.

Meeting highlights include:

3097.0 Foundations of Human Rights and Health
Monday, Nov. 6: 10:30 a.m.-12 p.m.
Featured presentation:

– Dual loyalty: Human rights and ethical challenges for the health professions; Leslie London, Professor, Leonard Rubenstein, JD, Lauren Baldwin Ragaven

3398.0 Global Climate Change, Clean Energy and Human Rights
Monday, Nov. 6: 4:30 p.m.-6 p.m.
Featured presentations:

– Science, politics and air quality policy; Samuel Dorevitch, MD, MPH

– Implications of environmental decline for public health ethics: Toward sustainable public health principles; Andrew Jameton, PhD

– Climate change, human rights and public health in an era of globalization; Dhananjaya Arekere, PhD, Brian Rivers, PhD, Lee Green, PhD

3115.0 Ensuring Food Safety and Emergency Preparedness
Monday, Nov. 6: 10:30 a.m.- 12 p.m.
Featured presentation:

– Food Defense: Awareness and Preparedness; Brenda Halbrook

3123.0 Policy Perspectives on Human Rights and Attention to HIV/AIDS Issues
Monday, Nov. 6: 10:30 a.m.-12 p.m.
Featured presentations:

– Towards a Rights-Based Approach to Sexual and Reproductive Health of Women Living with HIV/AIDS; Paul Perchal, MA, Lynn Collins, MD, Rasha Dabash, MA

– Criminal penalties for conduct that may threaten the public’s health: Trends in laws requiring mandatory HIV disclosure to prospective sex partners; C. Galletly, JD, PhD

– Program and policy tools to address HIV/AIDS, poverty and inequality; Marissa Billowtiz, MA, Marilyn Aguirre-Molina

3142.0 Immigrants’ Rights to Health in the U.S.A.
Monday, Nov. 6:10:30 a.m.-12 p.m.
Featured presentation:

– Legal and Health Policy Issues Regarding Immigrants’ Health in the United States: Whose Rights and Whose Responsibilities?; Mara K. Youdelman, JD, LLM

3210.0 Outbreak Investigations
Monday, Nov. 6: 12:30 p.m.-2 p.m.
Featured presentation:

– Managing Iowa’s Mumps Epidemic: Epidemiologists’ Experiences; Meghan Harris, BS, MPH, Sarah Brend, MPH, Pamila Deichmann, RN, MPH

3234.0 War and Public Health
Monday, Nov. 6: 12:30 p.m.-2 p.m.
Featured presentation:

– Physician-Soldier: The all-volunteer military and how it changed who serves in our name: Stephen K. Trynosky, JD, MPH

3301.0 Providing Insurance and Removing Barriers to Health Care for the Uninsured
Monday, Nov. 6: 2:30 p.m.-4 p.m.
Featured presentations:

– Health care reform in Massachusetts: Politics, progress and impact on vulnerable populations; Michael Doonan, PhD

– Exploring the relationship between state-level minimum wage policies and health-related outcomes: An analysis of 2004 BRFSS data; Kelly P. McCarrier, MPH

3303.0 Experiences and Exercises in Responding to Epidemics and Bioterror Events
Monday, Nov. 6: 2:30 p.m.-4 p.m.
Featured presentations:

– Pandemic influenza functional exercise – New Hampshire, 2005; Rachel Plotinsky, MD, Elizabeth A. Talbot, MD, Mary Ann Cooney, RN, Jose Montero, MD

– Avian overture: How pandemic training builds public health and safety partnerships; Mary Clark, JD, MPH, Kerry Dunnell, MSW, Garrett W. Simonsen, MSPS

3310.0 Planning for Pandemic Influenza: Local, State, Tribal and Federal Perspectives
Monday, Nov. 6: 2:30 p.m.-4 p.m.
Featured presentations:

– Planning for Pandemic Influenza: Federal Perspective; Pascale Wortley, MD, MPH

– Planning for Pandemic Influenza: State Perspective; Paul Lewis

– Planning for Pandemic Influenza: Local Perspective; Paul Etkind, DrPH, MPH

– Planning for Pandemic Influenza: A Tribal Perspective; Jim Roberts

3394.0 Increasing Access to Medicaid and Providing Prescription Assistance to the Uninsured and the Underinsured
Monday, Nov. 6: 4:30 p.m.-6 p.m.
Featured presentations:

– Prescription assistance program: Helping to alleviate the burden of the high cost of prescription drugs for uninsured and underinsured; Deborah Delay, LCSW, Bruce Cooper, MD, MSPH, Carol Plock, MSW, John F. Newman, MSBA, Ann E. Martin, BA

– Impact of Medicaid cuts on patients seeking emergency room care; Heidi L. Allen, MSW, Briar Ertz-Berger, MD, Robert A. Lowe, MD, MPH, Katherine J. Riley, EdD

3418.0 Terrorism and Public Health
Monday, Nov. 6: 4:30 p.m.-6 p.m.
Featured presentations:

– Health effects among New York City residents as a result of 9/11; Philip J. Landrigan, MD, MSc

– Torture and medical complicity: Where we stand; Leonard Rubenstein, JD

– Civil liberties; H. Jack Geiger, MD, MsciHyg

4030.0 Public Health Consequences of Food Insecurity
Tuesday, Nov. 7:8:30 a.m.-10 a.m.
Featured presentation:

– Linking food insecurity and child development: The development effects of food insecurity in young, low-income Black and Latino children; Madina Agenor, AB, Stephanie Ettinger de Cuba, MPH, Ruth Rose-Jacobs, ScD, Deborah A. Frank, MD, Suzette Levenson, MPH, Med

4072.0 Human Rights Strategies to End Violence
Tuesday, Nov. 7: 10:30 a.m.-12 p.m.
Featured presentations:

– Chronic conflict and the right to health; Alicia Ely Yamin, JD, MPH

– Human rights strategies to stop genocide and crimes against humanity; Leonard Rubenstein, JD

4074.0 Global Sexual and Reproductive Health and Rights
Tuesday, Nov. 7: 10:30 a.m.-12 p.m.
Featured presentations:

– Human rights as a tool to promote a social determinants approach to reproductive health; Catherine Albisa, JD

– Intersection between HIV/AIDS and sexual and human rights; Alejandro Saavedra, MD, MPH

4199.0 Human Rights Issues in Response to Emergencies
Tuesday, Nov. 7: 2:30 p.m.-4 p.m.
Featured presentations:

– Assessing the nutritional status of children in Darfur: Challenges and successes; Leisel Talley, MPH

– Human rights in disasters: An overview, Samir N. Banoob, MD, PhD

4227.0 Public Health Emergencies and Human Rights
Tuesday, Nov. 7: 2:30 p.m.-4 p.m.
Featured presentations:

– Domestic Spying, Public Health Surveillance, and Human Rights; Wendy K. Mariner, JD, LLM, MPH

– HIV/AIDS in Africa: Taking Health and Human Rights Seriously; Evelyne Shuster, PhD

4290.0 What’s Happening in Our Communities? Tobacco-Related Health Disparities
Tuesday, Nov. 7: 4:30 p.m.-6 p.m.
Featured presentations:

– Disproportionate cost of smoking for communities of color; Wendy Max, PhD, Hai-Yen Sung, PhD, Lue-Yen Tucker

– Smoking initiation among adolescent females: Does price sensitivity vary by weight and body image?; Julie H. Carmalt, MS

4324.0 25-Year History of AIDS: The U.S., Israel and South Africa on the Anniversary of the Epidemic
Tuesday, Nov. 7: 4:30 p.m.-6 p.m.
Featured presentations:

– Health policy and (non)citizenship: Migrant workers and HIV/AIDS in Israel; Nadav Davidovitch, MD, MPH, PhD, Dani Filc, MD, PhD

– Shattered dreams? Doctors and nurses confronting the AIDS epidemic in South Africa; Gerald Oppenheimer, PhD, MPH

5088.0 Katrina: Through the Lens of Public Health and Human Rights
Wednesday, Nov. 8: 10:30 a.m.-12 p.m.
Featured presentations:

– Rising from the ashes: Starting over after Hurricane Katrina; Cheryl Bowers-Stephens, MD, MBA

– Public health system: Overcoming the ravages of Katrina; Lovetta Ann Brown, MD, MPH, CP

– Environmental policies: From moldy words to meaningful change; Maureen Lichtveld, MD, MPH

5091.0 Pandemic Influenza: Non-Pharmacologic Interventions
Wednesday, Nov. 8: 10:30 a.m.-12 p.m.
Featured presentations:

– From SARS and bioterrorism to pandemic flu, new tools and old medicine: Non-pharmaceutical interventions as a way to protect ourselves against contagious disease; David Heyman

– Ethical issues with pandemic flu; Robert J. Levine, MD

– Community engagement; Donna L. Richter, EdD, FAAHB

5178.0 Women’s Choices in Childbirth – Access to Care
Wednesday, Nov. 8: 2:30 p.m.- 4 p.m.
Featured presentations:

– Myth of the Maternal Request Cesarean: Exploring Mothers Attitudes Toward Cesarean Birth; Eugene Declercq, PhD

– White Ribbon Alliance: Women and Infants Service Package (WISP): Planning for Emergencies; Lisa Summers, CNM, DrPH

– Case Against Elective Primary Cesarean Surgery; Henci Goer, BA

Founded in 1872, the APHA is the oldest, largest and most diverse organization of public health professionals in the world. The association aims to protect all Americans and their communities from preventable, serious health threats and strives to assure community-based health promotion and disease prevention activities and preventive health services are universally accessible in the United States. APHA represents a broad array of health providers, educators, environmentalists, policy-makers and health officials at all levels working both within and outside governmental organizations and educational institutions.

More information is available at apha.

DNDi Inaugurates Africa’s First Clinical Research Facility For Visceral Leishmaniasis In Ethiopia

Africa’s first clinical research facility dedicated to visceral leishmaniasis (VL), was inaugurated by the Drugs for Neglected Diseases initiative (DNDi) on February 9 in the presence of the regional authorities of Ministry of Health, and members from Addis Ababa University (AAU). The Leishmaniasis Research and Treatment Centre (LRTC) is located in Arba Minch, southern Ethiopia.

“This facility marks an important step in meeting the needs of VL patients who have been neglected because of a lack of access to appropriate diagnosis and treatment,” remarked Catherine Royce, DNDi Leishmaniasis Project Manager.

Built by DNDi, with funds provided by the Leopold Bachmann Foundation, a Swiss philanthropic organization, the LRTC will function both as a treatment and research facility for patients suffering from VL, also known as kala-azar. Affecting patients who mostly live in areas where access to health care is minimal, VL is a deadly disease that claims thousands of lives a year.

Professor Asrat Hailu, a senior researcher in the Faculty of Medicine at Addis Ababa University, commented, “In a country where research is not yet fully considered as a part of the solution to the problems that face us, and hence where capacity for clinical research is rudimentary, the roadmap of DNDi could not have been more timely.”

The LRTC is part of DNDi’s Leishmaniasis East Africa Platform (LEAP) that brings together a regional group of scientists and institutions working on developing clinical trial capacity to bring new treatments to patients suffering from VL. LEAP currently involves clinical trial sites in 3 countries – Ethiopia, Sudan, and Kenya.

With an inclusive strategy that utilizes existing expertise in disease-endemic regions, DNDi currently has eight projects focused on leishmaniasis – 2 in the early drug discovery stage, 3 in preclinical studies, and 3 in clinical testing. Because current treatment requires a 30-day course of painful injections given in a hospital, there is a need for both immediate improvements in terms of availability and cost as well as longer-term innovation in terms of efficacy and prevention of resistance.

Bernard Pecoul, Executive Director of DNDi, emphasized, “The goal of DNDi’s portfolio strategy for VL is to work towards a well-balanced range of projects. We are working to ensure that patient needs are urgently met with the best science for the most neglected.”

The Leishmaniasis East Africa Platform (LEAP) currently involves partner institutions in three countries: in Kenya, the Kenya Medical Research Institute (KEMRI) and the Ministry of Health; in Ethiopia, Addis Ababa University (AAU), the Drug Administration and Control Authority (DACA), and the Ministry of Health; and in Sudan, the University of Khartoum, the Federal Ministry of Health, and MSF-Holland. The role of LEAP is to facilitate clinical testing and registration of new treatments for VL in the region; to evaluate, validate and register improved options that address regional needs for leishmaniasis; and to provide capacity strengthening for drug evaluation and clinical studies in the region.

The Leishmaniasis Research and Treatment Centre (LRTC), Africa’s first clinical research facility dedicated to visceral leishmaniasis (VL), was opened in February 2006 by DNDi in Arba Minch, Ethiopia. The building is part of Arba Hospital and was built by Mr. Mekonnen Zeyeye and Mr. Feyisa Kefene. The building has 24 beds, separate examination and treatment rooms, a laboratory, offices for medical personnel, a rest area for patients and families, cooking facilities, and a water storage tank.

Pictures of the facility and ceremonies, as well as further information on DNDi & LEAP are available at dndi.

An MP3 Recorder/Player Could Replace The Traditional Stethoscope

With better quality sound, reproducibility potential for computer analysis, file-sharing and verification, this new approach offers many benefits, as two Canadian researchers tell the ERS annual Congress in Stockholm.

The traditional stethoscope, fast approaching its second centenary, could soon have to give way to new digital technologies, which are undergoing spectacular development. Even the latest electronic stethoscopes cannot rival MP3 players, used today mainly for leisure purposes.
So explained Neil Skjodt, of the Department of Medicine at the University of Alberta (Edmonton, Canada), in his presentation to the annual Congress of the European Respiratory Society (ERS) in Stockholm.

Working with an audiologist colleague, Bill Hodgetts, Skjodt based his analysis on the conclusions of several recent studies, which had demonstrated that health care staff generally had mediocre auditory faculties, especially when using stethoscopes.
In particular, a Danish study had shown two years earlier that medical staff at all levels had difficulty distinguishing most heart and lung sounds, and that their performance barely improved when they used an electronic stethoscope.

Two more recent studies had found that medical students sometimes had to listen to certain clinical sounds up to five hundred times before they could recognise them accurately.
Yet there are few electronic instruments that make it possible easily to record, reproduce or store the sounds heard during a medical consultation. Not to mention the possibility of transmitting such sounds to databanks so that other doctors may refer to them later.

Better than a stethoscope

At the same time, the increasingly popular portable MP3 recorder/players, used primarily for music, are selling in vast numbers and becoming a major presence on the market.
This gave Skjodt and Hodgetts the idea of studying whether the classical stethoscope could be replaced by a cheap off-the-shelf MP3 recorder/player.

By pressing its microphone directly to the chest, they were able to record a whole range of respiratory sounds with different patterns. Different baseline breath sounds with or without added wheezing were studied.
“The quality, clarity and purity of the loud sounds were better than I have ever heard with a stethoscope”, Skjodt told the Stockholm audience.
The MP3 files were later transferred to a computer and converted into frequency curves. Computer analysis of the stored sounds showed that each had a distinct signature. The computer – like the human ear – did, however, sometimes have difficulty in processing complex or quiet breathing sounds.

Skjodt then tested the trainee respiratory specialists to identify the MP3 recordings of breath sounds- with mixed but promising results. Wheezing noises were recognized much better than in similar historic studies, but differences in baseline breath sounds and in recognizing combinations were still not better than chance.
Skjodt and Hodgetts plan to see if brief training and ability to use reference recordings could improve auditory recognition.

Unequalled multi-tasking potential

“The improved quality is only one of the benefits”, Skjodt emphasised, “and there would be many other advantages to using an MP3 device instead of a stethoscope.” Indeed, the recorded breathing sounds can be included in the patient’s file for future reference. They can also be sent to a specialist, or processed with more sophisticated software for particularly detailed analysis.
In addition, the MP3 recorder can, of course, be used to replace an ordinary dictaphone for medical reports, or to register conferences, as well as patient interviews. And, naturally, to listen to music out of hours??¦

The Canadian researchers will now continue their study, examining other clinical sounds and assessing the impact of more highly developed audio techniques on sound recognition by the human ear.
Doctors could find this particularly useful at patients’ bedsides.

European Respiratory Society

Nontuberculous Mycobacteria Lung Disease On The Rise In The United States, Study Finds

Nontuberculous mycobacteria (NTM) are environmental organisms found in both water and soil that can cause severe pulmonary (lung) disease in humans. Pulmonary NTM is on the rise in the United States, according to a large study of people hospitalized with the condition.

A research team led by epidemiologists from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, analyzed hospital discharge records of patients in 11 states whose combined total population represents 42 percent of the country. They reviewed database records spanning 1998 to 2005, and identified more than 16,475 hospitalizations associated with pulmonary NTM in people without AIDS. Before the widespread availability of combination antiretroviral therapy, pulmonary NTM disease was a common opportunistic infection among people with AIDS infection; in this study, the researchers limited their analysis to non-AIDS NTM disease.

Of the 11 states studied, Florida, New York and California had 62 percent of the pulmonary NTM hospitalizations. The scientists chose these states to compare trends by geographic area. They found the annual prevalence of disease increased significantly among men and women in Florida (3.2 percent per year for men and 6.5 percent per year for women) and among women in New York (4.6 percent per year). There were no significant changes in California. Whether these geographic differences in prevalence are a result of exposure to NTM, or increased concentrations of mycobacterium in certain environments, or both, is not clear. However, previous studies have found high disease prevalence in the southeastern United States, particularly along the coastal regions of the Atlantic and Gulf coasts.

Study results show pulmonary NTM has increased in certain geographic areas of the United States, and while overall prevalence is higher in women, prevalence increases for both sexes in the fifth or sixth decade of life. Further research is needed to define the prevalence of the disease in nonhospitalized people in regions throughout the United States and to determine risk factors for disease susceptibility, including genetic and environmental factors.

Article:


Hospitalizations for nontuberculous mycobacteria-associated lung disease, United States, 1998-2005. Emerging Infectious Diseases.DOI: 10:3201/eid510.090196 (2009).

Who:


D. Rebecca Prevots, Ph.D., Head, Epidemiology Unit, NIAID Laboratory of Clinical Infectious Disease

Source:
Linda Perrett

NIH/National Institute of Allergy and Infectious Diseases

NASONEX(R) Now FDA-Approved in USA for Nasal Polyps

First and only nasal inhaled steroid in US for treatment of this condition –

Schering-Plough Corporation (NYSE: SGP) today announced that the US Food and Drug Administration (FDA) has approved
NASONEX(R) (mometasone furoate monohydrate) Nasal Spray, 50 mcg* for the treatment of nasal polyps in patients 18 years of
age and older.(1) This marks the first and only FDA-approval of a nasal inhaled steroid for the treatment of this condition
prior to surgery. Nasal polyps are grape-like growths in the nasal cavity that reduce airflow in the nasal passages, leading
to congestion.

“The approval of NASONEX for the treatment of nasal polyps provides patients with a safe and effective first-line treatment
that delivers medicine directly to the problem area,” said Robert J. Spiegel, M.D., chief medical officer and senior vice
president, Schering-Plough. “NASONEX, used once or twice daily, reduces nasal polyps and relieves symptoms, including
congestion.”

The new indication for NASONEX is based on data submitted from two controlled trials involving 664 patients 18 to 86 years of
age. Patients received either NASONEX 200 mcg once daily, NASONEX 200 mcg twice daily or a placebo. In the first study, a
statistically significant reduction in polyp grade was observed at the four-month endpoint in patients receiving NASONEX 200
mcg either once or twice daily, compared to the placebo group. In the second study, patients receiving NASONEX twice daily
demonstrated significant reduction of polyp grade compared to the placebo group, and patients receiving once-daily
administration demonstrated a numerical but not significant reduction in polyp grade. Both studies showed a statistically
significant reduction in congestion for both doses versus the placebo group. Based on the data, the approved indication
recommends a 200 mcg dose given twice-daily. A dose of 200 mcg once-daily also is effective in some patients.

On Nov. 24, NASONEX received approval for the treatment of nasal polyps in 13 European countries via the European Union’s
Mutual Recognition Procedure. The countries involved in the Mutual Recognition Procedure included the United Kingdom, which
acted as the reference Member State, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Luxembourg, the
Netherlands, Portugal and Spain. The data also will be reviewed for approval nationally in other European Union member
states.

About Nasal Polyps

Nasal polyps often appear in the mucous lining of the nose or in the sinuses. When inflammation in the nose occurs, blood
vessels may become porous, which allows water to accumulate in the cells. Polyps develop and grow as fluid builds in the
tissue.

The prevalence of nasal polyps increases with age and the condition affects up to 2- to- 4 percent of people in the United
States.(2) The exact cause of nasal polyps is unknown. Nasal polyps often are seen in people with asthma. Approximately 13
percent of people with nonallergic asthma develop nasal polyps.(3) Symptoms of nasal polyps include long-term nasal
congestion, diminished sense of smell, runny nose, chronic sinus infections, headaches or snoring. When polyps obstruct the
nasal cavity, mucus is unable to drain properly. Surgical removal is commonly used as a last resort.

About NASONEX

Originally approved in 1997, NASONEX remains the first and only once-daily prescription nasal inhaled steroid approved to
help prevent most seasonal nasal allergy symptoms, including nasal congestion, in adults and children 12 years of age and
older and the only nasal inhaled steroid approved to treat nasal allergy symptoms, including nasal congestion, in patients as
young as 2 years of age.(1) As a result of today’s approval, NASONEX also is indicated for the treatment of nasal polyps in
adults 18 years of age and older. NASONEX is a nasal inhaled steroid related to cortisol, a hormone produced naturally by the
body, and when used as directed is safe and nonsedating. NASONEX reduces nasal congestion caused by an allergic reaction.
NASONEX provides relief from the nasal symptoms of seasonal and perennial allergic rhinitis, including nasal congestion,
sneezing and an itchy, runny nose. Side effects were generally mild and included headache, viral infection, sore throat,
nosebleeds, and coughing. Visit NASONEX for full prescribing information and for more information on treating
nasal allergies and polyps. For additional important safety information, full prescribing information also is available at:
spfiles/pinasonex.pdf.

NASONEX builds upon Schering-Plough’s heritage as a leader in discovery and development. Products from the company’s research
efforts include the CLARITIN(R) (loratadine) family of nonsedating antihistamines and CLARINEX(R) (desloratadine) syrup and
tablet.

DISCLOSURE NOTICE: The information in this press release includes certain “forward-looking” statements within the meaning of
the Securities Litigation Reform Act of 1995, including the market for drugs to treat nasal polyps and NASONEX’s market
potential. Forward-looking statements relate to expectations or forecasts of future events and use words such as “may” and
“will.” Actual results may vary from the forward-looking statements, and there are no guarantees about the performance of
Schering-Plough stock or Schering-Plough’s business. Schering-Plough does not assume the obligation to update any
forward-looking statement. Many factors could cause actual results to differ from Schering-Plough’s forward-looking
statements. These factors include market acceptance of new products and new indications, regulations impacting pricing of
pharmaceutical products, matters impacting patents on Schering-Plough products, competitive pressures including the
introduction of generic products, manufacturing issues, and the regulatory process for new products and new indications. For
further details about these and other factors that may impact the forward-looking statements, see Schering-Plough’s
Securities and Exchange Commission filings, including the 2004 third quarter 10-Q.

Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products.
Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets
advanced drug therapies to meet important medical needs. Schering-Plough’s vision is to earn the trust of the physicians,
patients and customers served by its more than 30,000 people around the world. For additional information, visit schering-plough.

* Calculated on the anhydrous basis.
1. NASONEX(R) Product Information. Schering Corporation.
2. Mygrind N., Dahl R., Rachert C. Nasal polyposis, eosinophil dominated
inflammation, and allergy. Thorax. 2000;5S(Suppl 2):S79-S83.
3. Grigoreas C., et.al. “Nasal polyps in patients with rhinitis and
asthma.” Allergy Asthma Proc. 2002 May-Jun;23(3):169-74.
Media: Mary-Frances Faraji, +1-908-298-7109, or Julie Lux,
1-908-298-4774, Investor: Janet Barth, or Alex Kelly, +1-908-298-7436, all of Schering-Plough Corporation

View drug information on Nasonex Nasal Spray.

Teikoku Pharma USA And Eisai Co., Ltd Announce Licensing Agreement For A New 7-Day Transdermal Formulation Of Donepezil

Teikoku Pharma USA Inc., the international specialty pharmaceutical company, announces that it has signed an exclusive worldwide (excluding Japan) licensing agreement with Eisai Co., Ltd. to develop and commercialize a new transdermal formulation of donepezil, a leading compound for the treatment of Alzheimer’s disease in the world.

The transdermal formulation is a once-a-week patch that continuously delivers donepezil through the skin into the bloodstream. It will enable the number of doses to be reduced, make it easier to be used for patients with Alzheimer’s disease who have difficulty in swallowing, and also reduce the burden of caregivers or family members when administering it to patients.

About Teikoku

Teikoku Pharma USA Inc. is a wholly-owned subsidiary of Teikoku Seiyaku Inc., a specialty pharmaceutical company that develops, and manufactures enhanced pharmaceutical products based on its transdermal drug delivery technologies. Teikoku focuses its efforts in two therapeutic areas; chronic and acute Pain and CNS. Teikoku’s main product is Lidoderm® (lidocaine 5% patch) for PHN (post herpetic neuralgia), in collaboration with Endo Pharmaceuticals in the US, Grunenthal GmBH in Europe, Mundipharma in South East Asia and SK Pharma for Korea.

Teikoku’s commitment is to expand Trandermal technologies for the benefit of patients and partners. For more information, please visit teikokuusa.

About Eisai

Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: integrative neuroscience, integrative oncology, and vascular/immunology reaction. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. With operations in the U.S., Asia, Europe and its domestic home market of Japan, Eisai employs more than 10,000 people worldwide. For more information, please visit eisai.jp.

Eisai

View drug information on Lidoderm Patch.